- United Therapeutics (Silver Spring, MD)
- …detail and managing the change control process is second nature to you. The GxP Systems Analyst, Operational Technology will provide application support for the ... requirements. + Ensure the continuous, uninterrupted availability and functionality of computer systems , and coordinate appropriate resources to respond to… more
- Jabil (Hunt Valley, MD)
- …for cGMP manufacturing. + Demonstrate SME-level knowledge of process/equipment validation , computer systems , standards, and GxP regulations. Expertise in ... activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process in compliance with global regulatory… more
- System One (Princeton, NJ)
- …Lead Validation Specialist with a strong background in clinical systems and computer systems validation to join our growing team. In this role, ... lead validation initiatives to ensure that all systems are compliant with GxP regulations and...degree required. + 8+ years of professional experience in computer systems validation within life… more
- Endo International (St. Louis, MO)
- …and review. The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other ... OQ, PQ, and PV + Review and approval of validation documents including but not limited to: GxP...Interaction with colleagues at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation… more
- Astellas Pharma (South San Francisco, CA)
- … Validation Engineer plans and executes risk-based qualification and computerized systems validation activities in cell and gene therapy research environments ... , Computer Science, Life Sciences. + 8+ years of Computerized Systems Validation experience with hands-on authorship and execution of URS, specifications,… more
- Medtronic (Juncos, PR)
- …related to manufacturing and automation equipment. This includes developing and performing validation protocols to ensure equipment, systems , and processes meet ... , vision inspection systems , robotics, and digital factory technologies. + Ensure validation packages comply with FDA 21 CFR Part 11, ISO 13485, EU MDR, and… more
- Lilly (Concord, NC)
- …We are seeking a highly experienced Principal Engineer to lead and execute validation activities for our Global TSMS (Technical Systems Management System) ... to regulatory requirements. Technical Expertise: Provide expert technical guidance on validation methodologies, data integrity principles, GxP regulations, and… more
- Cognizant (Boston, MA)
- …Oversee interoperability validation to guarantee seamless integration across platforms and systems . + Manage Computer System Validation (CSV) activities ... will make an impact by leading the testing and validation strategy for enterprise-level Document Management Systems ...to have to be considered** + Deep knowledge of GxP regulations and global compliance standards (eg, 21 CFR… more
- Lilly (Boston, MA)
- …Publications on model validation , benchmarking, or reproducibility + Experience with GxP compliance and quality management systems + Exceptional attention to ... and characterization methods + Familiarity with RNA therapeutic design and delivery systems + Experience with clinical biomarker validation and translational… more
- Danaher Corporation (Chaska, MN)
- …Knowledge of FDA regulations, ISO standards, and GxP guidelines. + Experience with Computer System Validation (CSV) and process validation It would be a ... world, more than one million tests are run on Beckman Coulter Diagnostics systems , impacting 1.2 billion patients and more than three million clinicians per year.… more
- Bristol Myers Squibb (Devens, MA)
- …Sciences, or related field. + 7+ years of experience managing laboratory IT systems in a GMP or GxP -regulated pharmaceutical manufacturing or research ... informatics systems (eg, LIMS, CDS, SDMS, ELN) and corresponding validation requirements. + Demonstrated experience leading complex IT or digital projects,… more
- Sumitomo Pharma (St. Paul, MN)
- …+ Define the architecture, solution design, and technical roadmap for critical GxP systems supporting Clinical Supply Chain, Commercial Operations, Quality ... and Manufacturing), Salesforce ATM (for Patient/Order/Cell Orchestration), SAP CGTO, and other GxP systems . + Translate complex business requirements related to… more
- Bristol Myers Squibb (Devens, MA)
- …instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would encompass various instrument types such as ... and technical support. + Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the… more
- Edwards Lifesciences (Draper, UT)
- …small to medium IT projects * Experience with FDA guidelines for Software Quality and Systems Validation * Proven expertise in usage of MS Office Suite * Strong ... Leadership **What you'll need (Required):** * Bachelor's degree in Computer Science or a related field, and a minimum...Prefer experience with FDA guidelines for Software Quality and Systems Validation is a plus * Experience… more
- Pfizer (Pearl River, NY)
- …complex liquid handler methods and (ii) authoring qualification and validation documents, change control requests, and standard operating procedures (SOP), ... assigned, (iii) participating in activities associated with the method validation /verification process or equipment qualification process. In addition, the Associate… more
- MetaOption, LLC (Sunnyvale, CA)
- …software platforms. You will ensure reliability, scalability, and compliance of critical systems in alignment with FDA GxP guidelines and HITRUST standards ... (Kubernetes, Docker), cloud platforms, and infrastructure-as-code. * Direct experience supporting systems subject to FDA GxP and HITRUST compliance; familiarity… more
- Bristol Myers Squibb (Devens, MA)
- …managing a large budget. + Experience in Computer System Validation , Analytical Methods development/transfer, Quality Systems , Product Quality complaint, ... enterprise KPIs , and overseeing SOPs, training, and digital quality systems (including GxP AI governance). With a forward-looking approach, this leader engages… more
- J&J Family of Companies (Santa Clara, CA)
- …Senior Quality Engineer- NPS CSV provided Quality Assurance oversight for non-product software systems used in GxP regulated environments including systems ... risk-based validation , and Quality System expectations related to digital systems . **Qualifications** : + Minimum 6 years of experience in Quality Assurance… more
- Astellas Pharma (South San Francisco, CA)
- …SCADA, DCS, OPC DA/UA, RDBMS, MODBUS. + Technical SME and system administrator for assigned systems , which will include GxP systems (control systems for ... **Senior Engineer, Lab Systems and Applications** Do you want to be...solutions in support of business processes + Experience with computer system validation + Experience using multiple… more
- Amgen (Holly Springs, NC)
- …Installation Verification/Automation Check Out (IV/ACO) + Support QA partners in performing computerized systems validation in a GxP environment + Perform ... part of Amgen's plan to be a carbon-neutral company by 2027. **Senior Manufacturing Systems Engineer: Automation - DeltaV** **What you will do** Let's do this. Let's… more